Resources for Food and Drug Administration (FDA)

F.D.A. and Disk Maker Questioned

www.nytimes.com

A ranking member of the Senate Finance Committee has asked the Food and Drug Administration and the maker of an artificial spinal disk about potential financial conflicts of many of the doctors involved in the clinical research that led to F.D.A. approval of the device.

The financial relationships were the subject of a front-page New York Times article in late January. Doctors at about half the research centers involved in the study of the artificial disk, the Prodisc, had a direct financial interest in the device’s success.

Prodisc, originally made and tested by an American company, is now manufactured by the Swiss manufacturer Synthes, whose United States headquarters received a letter of inquiry on late Tuesday from Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee. The F.D.A. received a letter from Mr. Grassley on Wednesday.

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